Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 104, Issue 2, Pages 433-446Publisher
ELSEVIER SCIENCE INC
DOI: 10.1002/jps.24126
Keywords
excipients; protein formulation; microscopy; infrared spectroscopy; microparticles; FTIR
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We report, for the first time, the identification of fatty acid particles in formulations containing the surfactant polysorbate 20. These fatty acid particles were observed in multiple mAb formulations during their expected shelf life under recommended storage conditions. The fatty acid particles were granular or sand-like in morphology and were several microns in size. They could be identified by distinct IR bands, with additional confirmation from energy-dispersive X-ray spectroscopy analysis. The particles were readily distinguishable from protein particles by these methods. In addition, particles containing a mixture of protein and fatty acids were also identified, suggesting that the particulation pathways for the two particle types may not be distinct. The techniques and observations described will be useful for the correct identification of proteinaceous versus nonproteinaceous particles in pharmaceutical products. (c) 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:433-446, 2015
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